Table 3.
Adverse events.
| DIAGNOSIS | n | SEVERITY (n) | CAUSALITY: RELATION TO STUDY DRUG (n) |
|---|---|---|---|
| Abdominal discomfort | 6 | Moderate (4), Mild (2) | Likely (6) |
| Abdominal distension | 4 | Moderate (2), Mild (2) | Unknown (1), Likely (3) |
| Abdominal pain | 8 | Severe (4), Moderate (3), Mild (1) | Unknown (3), Likely (5) |
| Diarrhea | 2 | Mild (2) | Unknown (1), Likely (1) |
| Eructation | 3 | Mild (2), Moderate (1) | Unknown (1), Likely (2) |
| Flatulence | 1 | Moderate | Unknown |
| Gastric upset | 6 | Moderate (1), Brando (5) | Unknown (1), Likely (5) |
| Halitosis | 1 | Moderate | Likely |
| Headache | 4 | Moderate (2), Mild (2) | Unknown (3), Likely (1) |
| Insomnia | 4 | Severe (1), Moderate (1), Mild (2) | Unknown (3), Likely (1) |
| Irritability | 8 | Moderate (5), Mild (3) | Unknown (2), Likely (6) |
| Light sleep | 1 | Moderate | Unknown |
| Memory loss | 1 | Mild | Unknown |
| Mood swings | 1 | Mild | Unknown |
| Nausea | 2 | Mild | Likely (2) |
| Nightmares | 1 | Severe | Unknown |
| Oily skin | 2 | Moderate (1), Mild (1) | Unknown (2) |
| Polyuria | 1 | Moderate | Unknown |
| Pruritis | 1 | Moderate | Unknown |
Abbreviation: n, number of subjects.